The pain relief, safety, and tolerability of valdecoxib 40 mg once daily compared with diclofenac 75 mg twice daily for acute low back pain was studied. The effect of valdecoxib on the patient's level of disability and quality of life was also studied.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
340
valdecoxib 40 mg QD for 7 days with a second dose of 40 mg the first day
diclofenac 75 mg twice daily (BID) for 7 days
Subject-rated VAS Pain Intensity (0 - 100 mm), which was evaluated using the change from baseline
Time frame: Day 3
Patient global evaluation
Time frame: Day 3 and Day 7
Subject's functional capacity as measured by the Oswestry Low Back Pain and Disability Questionnaire
Time frame: Day 7
Subject's quality of life as measured by the Acute short form (SF)-36 (8 domains)
Time frame: Day 7
Pain Relief
Time frame: Day 3 and Day 7
Composite Upper Gastrointestinal (UGI) Tolerability was calcluated. A subject had a UGI event if the subject reported at least 1 of the following: moderate or severe nausea, or moderate or severe abdominal pain, or moderate or severe dyspepsia
Time frame: Day 7
VAS Pain Intensity (0-100 mm)
Time frame: Day 7
Categorical Pain Intensity
Time frame: Day 3 and Day 7
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